BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE DISTAL COVER

    MDR report key: 16337535 · Received February 9, 2023

    Report

    Report Number
    3003637092-2023-00037
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    March 18, 2021
    Report Date
    February 9, 2023
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
    Product Code
    FDT
    UDI-DI
    04953170403019
    PMA / PMN Number
    K220587
    Removal / Correction Number
    Z-1292-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE ACTUAL PRODUCT WAS NOT RETURNED FOR EVALUATION, OLYMPUS PERFORMED A REPRODUCTION CHECK USING A REPRESENTATIVE DEVICE ACCORDING TO THE PROCEDURE IN THE INSTRUCTION MANUAL, BUT THE INDICATED PHENOMENON WAS NOT REPRODUCED. IN ADDITION, AS A RESULT OF PRODUCT STANDARDS TEST USING A REPRESENTATIVE DEVICE AGAINST THE RESISTANCE QUALITY STANDARD THAT "DOES NOT COME OFF FROM THE END OF THE SCOPE DURING USE", THE DEVICE SATISFIED THE PRODUCT STANDARD. THE ROOT CAUSE OF THE USER¿S REPORT CANNOT BE CONCLUSIVELY DETERMINED BUT THE MOST LIKELY CAUSES FOR THE REPORTED PHENOMENON (DISTAL END COVER FALLING OFF) ARE AS FOLLOWS: (1) THE DISTAL END COVER WAS EASILY REMOVED FROM THE SCOPE DUE TO INSUFFICIENT ATTACHMENT TO THE SCOPE. (2) WHEN THE COVER WAS ATTACHED TO THE SCOPE, THE COVER WAS DAMAGED BY PUSHING IT DIAGONALLY, MAKING IT EASY FOR THE COVER TO COME OFF THE SCOPE. (3) CHEMICAL SOLUTIONS SUCH AS ANTI-FOG AGENT ADHERED TO THE DISTAL END COVER, WHICH CAUSE THE DISTAL END COVER TO COME OFF THE SCOPE. OLYMPUS ALSO PERFORMED A REPRODUCTION CHECK USING A TEST SCOPE WITH A DISTAL COVER ATTACHED AND PIG ORGAN. REMOVAL OF THE TEST SCOPE FROM THE PIG ORGAN WAS EXPERIMENTED UNDER TWO PARAMETERS "DISTAL COVER WITH/WITHOUT SLIGHT CRACK" AND "SUCTION ACTIVATED/NOT ACTIVATED TO REMOVE THE SCOPE". THE TEST RESULT SHOWS THAT TISSUE IS EMBEDDED IN THE DISTAL COVER AFTER THE SCOPE IS REMOVED WITH SUCTION ACTIVATED, WHICH IS OBSERVED REGARDLESS OF "DISTAL COVER WITH/WITHOUT SLIGHT CRACK". MORE TISSUE IS EMBEDDED WHEN SMALL CRACK IS PRESENT ON THE DISTAL COVER AND SUCTION IS ACTIVATED DURING REMOVAL. THIS COULD CAUSE MORE SEVERE DAMAGE TO TISSUE. WHEN THERE IS NO CRACK ON THE DISTAL COVER AND SUCTION IS NOT ACTIVATED, NO TISSUE IS EMBEDDED IN THE DISTAL COVER. THE ROOT CAUSE OF THE USER'S REPORT CANNOT BE CONCLUSIVELY DETERMINED BUT THE MOST LIKELY CAUSES FOR THE REPORTED PHENOMENON (TISSUE DAMAGE) ARE AS FOLLOWS: 1) STARTED THE INSPECTION WITHOUT CONFIRMING THAT THE TIP COVER WAS PROPERLY ATTACHED DURING THE PRE-USE INSPECTION (START THE INSPECTION WITH THE TIP COVER CRACKED). 2) REMOVED THE ENDOSCOPE WITH THE TIP ADSORBED ON THE MUCOUS MEMBRANE BY SUCTION OPERATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THE DISTAL CAP THE DUODENOVIDEOSCOPE FELL OFF INTO THREE (3) PATIENT'S MOUTHS AS THE DEVICE WAS BEING REMOVED DURING THEIR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES. IT WAS INITIALLY REPORTED THAT ALL THREE (3) PATIENTS EXPERIENCED MINOR SCRATCHES/ABRASIONS IN THE ESOPHAGUS. THE PHYSICIAN BELIEVED THEY WERE CAUSED BY THE DUODENOVIDEOSCOPE. THE FOLLOWING WAS LATER REPORTED BY THE USER FACILITY: PATIENT 1 DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. THE CAP WAS RETRIEVED FROM THE PATIENT'S MOUTH BY THE PHYSICIAN. PATIENT 2'S PROCEDURE WAS ABORTED BECAUSE THE PHYSICIAN FELT THAT THE OUTER DIAMETER WAS BIGGER THAN THE CURRENT ERCP SCOPE TJF-Q180. THE CAP DID NOT FALL OFF IN THIS PROCEDURE. THERE WAS NO SCRATCH TO THE PATIENT'S ESOPHAGUS. THEREFORE THERE WAS NO DEVICE MALFUNCTION NOR ADVERSE EVENT EXPERIENCED. PATIENT 3'S SCRATCH TO THE ESOPHAGUS WAS DESCRIBED AS MILD, REQUIRED NO TREATMENT AND WAS IN STABLE CONDITION. THE PHYSICIAN USED TWO ADDITIONAL GIF-H190 SCOPES TO SEARCH FOR THE CAP AFTER IT FELL OFF, AND WAS UNSUCCESSFUL IN LOCATING IT WITH THE GIF SCOPES. THE PHYSICIAN THEN SEARCHED THE PATIENT'S MOUTH WITH HIS FINGERS UNTIL HE FOUND IT. THE FOLLOWING MEDWATCH REPORTS ARE RELATED WITH PATIENT IDENTIFIERS: (B)(6) TJF-Q190V / (B)(6) MAJ-2315 (PATIENT 1) (B)(6) TJF-Q190V / MAJ-2315 NOT REPORTED (PATIENT 2) (B)(6) TJF-Q190V / (B)(6) MAJ-2315 (PATIENT 3) THIS MEDWATCH IS FOR(B)(6) RELATED TO PATIENT IDENTIFIER (B)(6) WHICH WAS REPORTED UNDER MFR REPORT NUMBER 8010047-2021-04894.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607873 SINGLE USE DISTAL COVER DISTAL COVER FDT OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT MAJ-2315 UNKNOWN 04953170403019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TJF-Q190V : SN UNKNOWN